Positive Airway Pressure Therapy for Sleep Apnea

N/A

Recruiting

Research Sponsored by NovaResp Technologies Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have a new diagnosis of moderate or severe OSA (AHI > 15 events/hour)

Must be 18-70 years old

Must not have

Subjects actively using bi-level PAP or require oxygen therapy

Neuromuscular disease, hypoglossal-nerve palsy, severe restrictive or obstructive pulmonary disease, moderate-to-severe pulmonary arterial hypertension, severe valvular heart disease, New York Heart Association class III or IV heart failure, recent myocardial infarction or severe cardiac arrhythmias (within the past 6 months), persistent uncontrolled hypertension despite medication use, active psychiatric disease, and coexisting non-respiratory sleep disorders that would confound functional sleep assessment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare how well patients with newly diagnosed obstructive sleep apnea stick to their Positive Airway Pressure therapy. It will look at whether proactive therapy or conventional Automatic-PAP therapy is better

Who is the study for?

This trial is for adults aged 18-70 who have just been diagnosed with moderate or severe Obstructive Sleep Apnea (OSA), meaning they have more than 15 breathing interruptions per hour of sleep. Participants should be able to follow the study's procedures and understand English. Those with uncontrolled, severe heart or brain conditions cannot join.

What is being tested?

The study compares two treatments for OSA: Proactive CPAP Therapy and standard Automatic-PAP (APAP) Therapy. It looks at how well patients stick to these therapies over short-term (3 months) and long-term periods (12 months), as well as their health outcomes like airway blockage during sleep, nightly use, mask fit, and patient feedback.

What are the potential side effects?

While not specified here, common side effects of PAP therapy can include discomfort from the mask or straps, dry nose or throat, nasal congestion, runny nose, irritation on the skin where the mask sits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been newly diagnosed with moderate or severe sleep apnea.

Select...

I am between 18 and 70 years old.

Select...

I don't have severe heart or brain problems that aren't under control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I use a bi-level PAP machine or need oxygen therapy.

Select...

I do not have severe heart, lung, muscle, nerve conditions, uncontrolled high blood pressure, recent heart attack, severe sleep disorders or active psychiatric disease.